Biotech Values

[masterlongevity]

Biogen CC Yesterday at Goldman. Some comments on generic copaxone......



Good 2011 largely driven by positive data for BG12.

Drug for ALS can be transformational during 2012. First drug in 15 yrs for ALS reading out at end of year.

Will continue with stock buybacks and M&A, but no dividend.

Happy with P3 pipeline but starting to build early stage pipeline, including acquisitions.

Strength in MS throughout the world.

Doesn't know what impact biosimilars will have on industry. Regulatory pathway not yet defined, but convinced it will eventually have an impact and Biogen are preparing for that. Not yet putting a lot of money into it, but have partnered with Samsung. Biogen is concentrating more on own pipeline. Samsung really determined however. If the whole area does start to take off Biogen has an opportunity to increase their stake with Samsung to 50% from 15%. Most biologicals might not be reproducible because they cannot be reproduced exactly. No pathway yet. Biogen will certainly will not work on biosimilars of Biogen's own products.

Analyst:: Given BG12 data how are MS drugs positioned within Biogen?

Have a very clear path how to position Tysabri, Avonex and BG12.

BG12 to be filed 1h12.

Not getting into pricing strategy but not looking to be highest price in the market as demonstrated by Avonex.

How to position BG12 versus Avonex and Tysabri question reiterated by analyst?

Avonex is what it is and have not stopped investing in that. Has helped hundreds of thousands of patients.

Interferon has a lot of life left because no surprises or unknown safety issues.

Tysabri is and incredibly efficacious product that really does transform the lives of a lot of patients who take it. And now that we have a lot of risk stratification where jc virus negative patients are at v/low risk, Tysabri provides a really attractive option for those patients even for earlier use. That will be a growth product for us and will continue for some period of time. And bg12 has the potential to be a really major product. Disease is different in many patients and will choose different therapy.

Analyst: Gilenya has had small impact. What about bg12?

Gilenya has some safety concerns that will or won't play out in the real world. If they don't then it will take market share. We'll see with BG12. It seems to be safe and effective. It should go well, and if so, it will take share from ABCRS. We won't be calling on Avonex prescribers first however.

Analyst: What does generic Copaxone do to market? Does it switch attention away from other injectables?

Some docs believe these are interchangeable. Others not so. Don't see a huge impact except on Compaxone itself.

Analyst: What about IP surrounding BG12?

Will file Bg12 during 1h12. Expect approval 1h13 if approved based on 10 mth review. Feel they have good IP protection through mid twenty twenties. Have resolved the IP protection in the EU.

Ampyra going well outside US, similar to US. Going well.

Analyst: BG12 seems to be best of MS drugs. Is there an appetite to switch patients in the market?

Lots of switching in the market anyway. Patients switch when they relapse usually. There are more switchers than new patients every year. BG12 provides compelling choice. Not sure how many patients will switch if they are currently stable. Some will and some wont. Others even if stable want to get away from injections. Gilenya uptake is as Biogen predicted in their models. We are bullish for bg12.

Last question during BIIB CC at GS was on Tysabri?

Analyst:

With jcv assay being approved in the EU and pending in the US. Will it change the use of the drug?

This is what the Biogen CEO stated.

We would recommend that patients who are JCV negative get tested each year. We would recommend they stay on if negative. Even for a long period after conversion the risk is low. Evidence is now that the earlier someone is treated with Tysabri the better the outcome. How I think of this is if someone close to me had MS what would I want them to take, and if they were jcv negative, then Tysabri is an amazing choice for them because of the efficacy.

He was then interrupted mid drift by the analyst who said "over BG12?"

He answered "yeah, oh well I'm not going to say over bg12", followed by lots of laughter.

He then said, " I would say both would be excellent choices. Let me say that, hey."

It sounded to me that he clearly thought that Tysabri was the better choice and he would've left it at that except for the joking and the analyst interruption.

Then asked about taking full control of Tysabri he answered that the partnership with Elan is good but not going to get into M&A strategy.